Recruiting

Brain-Computer Interface

Sponsor:

Neuralink Corp

Code:

NCT06429735

Conditions

Tetraplegia/Tetraparesis

Quadriplegia

Cervical Spinal Cord Injury

Amyotrophic Lateral Sclerosis

Quadriplegia/Tetraplegia

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

N1 Implant

R1 Robot

Study Details

Brief summary:

The PRIME Study is a first-in-human early feasibility study to evaluate the initial clinical safety and device functionality of the Neuralink N1 Implant and R1 Robot device designs in participants with tetraparesis or tetraplegia. The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot, a robotic electrode thread inserter.

Conditions

Tetraplegia/Tetraparesis

Quadriplegia

Cervical Spinal Cord Injury

Amyotrophic Lateral Sclerosis

Quadriplegia/Tetraplegia

Study ID

NCT06429735

Start date

Jan 9, 2024

Status verified date

Jan, 2026

Completion date

Jan, 2031

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Severe quadriplegia (tetraplegia) due to spinal cord injury or amyotrophic lateral sclerosis (ALS) for at least 1 year without improvement, where quadriplegia is defined as having very limited or no hand, wrist, and arm movement and all levels below
  • Life expectancy ≥ 12 months.
  • Ability to communicate in English
  • Presence of a stable caregiver

Exclusion Criteria

  • Moderate to high risk for serious perioperative adverse events
  • Active implanted devices
  • Morbid obesity (Body Mass Index > 40)
  • History of poorly controlled seizures or epilepsy
  • History of poorly controlled diabetes
  • Requires magnetic resonance imaging (MRI) for any ongoing medical conditions
  • Acquired or hereditary immunosuppression
  • Use of smoking tobacco or other tobacco products
  • Psychiatric or psychological disorder
  • Brain MRI demonstrating hemorrhage, tumor, distorted or adverse anatomy.
  • Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Neuralink N1 Implant and R1 Robot

Implantation of the N1 Implant by the R1 Robot.

Interventions

N1 Implant

The N1 Implant is a type of implantable brain-computer interface

R1 Robot

The R1 Robot is a robotic electrode thread inserter that implants the N1 Implant.

Primary outcome measure

  • Device-Related Adverse Events (AE) [ Time Frame: 12 months post-implant ]
  • Procedure-Related Adverse Events (AE) [ Time Frame: 12 months post-implant ]

Central Contacts and Locations

Central contacts

Neuralink Clinical Team

(877) 398-4465clinical-team-ct@neuralink.com

Locations

Barrow Neurological Institute

Recruiting

Phoenix, Arizona, United States, 85013

Principal Investigator:

Francisco Ponce, MD

University of Miami

Recruiting

Miami, Florida, United States, 33136

Principal Investigator:

Jonathan Jagid, MD

More Information

Sponsor

Neuralink Corp

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Keywords

  • spinal cord injury
  • SCI
  • BCI
  • brain computer interface
  • ALS
  • quadriplegia
  • tetraplegic
  • paralysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-15. This information was provided to ClinicalTrials.gov by Neuralink Corp on 2026-01-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.